Addex Therapeutics(ADXN)

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Addex Leads CHF 2 Million Investment in Stalicla to Advance Precision Medicine in Neuropsychiatric Disorders
Globenewswire· 2025-06-30 05:00
Core Insights - Addex Therapeutics has made a strategic investment of CHF 2 million in Stalicla, a company focused on precision medicine for neurodevelopmental and neuropsychiatric disorders [1][2] - The investment aims to support Stalicla's portfolio of autism-focused drug candidates and its series C financing, while also enhancing Addex's commitment to advancing innovative treatments for CNS disorders [2][3] Company Overview - Addex Therapeutics is a clinical-stage biopharmaceutical company developing novel small molecule allosteric modulators for neurological disorders, with a lead drug candidate, dipraglurant, under evaluation for brain injury recovery [4] - Stalicla has raised over $50 million in equity and more than $30 million in non-dilutive funding, focusing on transforming treatments for neurodevelopmental disorders [3][4] Investment Details - The investment will enable Stalicla to advance its lead autism candidate STP1 and a second asset into Phase 2 trials, targeting specific subpopulations within autism spectrum disorder (ASD) [2][3] - Stalicla is also progressing its STP7 program (mavoglurant) for cocaine use disorders, which is the most advanced treatment candidate in development for this indication [2][3] Leadership Changes - As part of the investment, Addex CEO Tim Dyer has been appointed to Stalicla's Board of Directors and nominated as Chairman, indicating a deeper collaboration between the two companies [1][2]
Stalicla Secures CHF 2 Million Financing Led by Addex Therapeutics to Advance Precision Medicine Neurodevelopmental Disorder Programs
GlobeNewswire News Room· 2025-06-30 05:00
Core Insights - Stalicla SA has successfully closed a CHF 2 million financing round led by Addex Therapeutics to advance its precision medicine programs for neurodevelopmental disorders [1][2] - The financing will support Stalicla's operations and program development as it prepares for a Series C financing and partnerships for key programs [1][2] - Stalicla's DEPI precision neuro platform and its autism assets, STP1 and STP2, have garnered investor confidence, while the STP7 program (mavoglurant) is progressing towards Phase 3 trials [1][3] Company Overview - Stalicla SA is a clinical-stage biopharmaceutical company based in Switzerland, having raised over $50 million in equity and more than $30 million in non-dilutive funding to enhance treatments for neurodevelopmental disorders [3] - The company has developed a neuro precision development platform that identifies stratified patient subgroups, facilitating personalized treatment options [3] - Stalicla is preparing to initiate Phase 2 trials for its leading asset, STP1, targeting specific subpopulations within autism, while STP7 is advancing towards Phase 3 trials with funding from the US government [3] Leadership and Strategic Direction - Tim Dyer has been appointed to the Board of Directors of Stalicla and nominated as Chairman, indicating a strategic partnership with Addex Therapeutics [2] - Lynn Durham, CEO of Stalicla, emphasized the importance of this financing in reaching significant milestones, including transformative clinical trials in autism and substance use disorders [2] - Addex Therapeutics recognizes Stalicla's platform as world-leading in precision medicine for neurodevelopmental disorders and aims to support the advancement of these critical medicines [2]
Addex Therapeutics(ADXN) - 2025 Q1 - Quarterly Report
2025-06-20 10:00
[Unaudited Interim Condensed Consolidated Financial Statements](index=2&type=section&id=Unaudited%20Interim%20Condensed%20Consolidated%20Financial%20Statements) [Unaudited Interim Condensed Consolidated Balance Sheets](index=2&type=section&id=Unaudited%20Interim%20Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased to CHF 9.5 million by March 31, 2025, driven by lower cash and investment values Consolidated Balance Sheet Summary (in Swiss francs) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Current Assets** | | | | Cash and cash equivalents | 2,825,484 | 3,341,738 | | Total current assets | 3,197,278 | 3,541,363 | | **Non-Current Assets** | | | | Investment accounted for using the equity method | 6,239,691 | 7,087,142 | | Total non-current assets | 6,287,376 | 7,136,940 | | **Total Assets** | **9,484,654** | **10,678,303** | | **Liabilities & Equity** | | | | Total current liabilities | 1,056,812 | 802,093 | | Total non-current liabilities | 132,164 | 198,939 | | **Total Equity** | **8,295,678** | **9,677,271** | | **Total Liabilities and Equity** | **9,484,654** | **10,678,303** | [Unaudited Interim Condensed Consolidated Statements of Comprehensive Loss](index=3&type=section&id=Unaudited%20Interim%20Condensed%20Consolidated%20Statements%20of%20Comprehensive%20Loss) The company's net loss from continuing operations widened to CHF 1.47 million in Q1 2025 due to no revenue Statement of Comprehensive Loss Summary (in Swiss francs) | Account | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Revenue from contract with customer | - | 233,480 | | Operating loss | (606,262) | (788,092) | | Share of net loss of investment (equity method) | (847,451) | - | | **Net loss from continuing operations** | **(1,472,863)** | **(735,178)** | | Net loss from discontinued operations | - | (2,351,961) | | **Net loss for the period** | **(1,472,863)** | **(3,087,139)** | | **Total comprehensive loss for the period** | **(1,406,841)** | **(3,135,856)** | | Basic and diluted loss per share (Total) | (0.01) | (0.03) | [Unaudited Interim Condensed Consolidated Statements of Changes in Equity](index=4&type=section&id=Unaudited%20Interim%20Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Equity) Total equity declined by CHF 1.38 million to CHF 8.30 million in Q1 2025, primarily due to the period's net loss Changes in Equity for Q1 2025 (in Swiss francs) | Description | Amount | | :--- | :--- | | **Balance as of January 1, 2025** | **9,677,271** | | Net loss for the period | (1,472,863) | | Other comprehensive income for the period | 66,022 | | Value of share-based services | 24,917 | | Net sales of treasury shares | 331 | | **Balance as of March 31, 2025** | **8,295,678** | [Unaudited Interim Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Unaudited%20Interim%20Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operations was CHF 0.6 million, leading to a quarter-end cash balance of CHF 2.8 million Statement of Cash Flows Summary (in Swiss francs) | Cash Flow Category | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | (598,706) | (2,194,379) | | Net cash from financing activities | 97,991 | 164,548 | | **Decrease in cash and cash equivalents** | **(500,715)** | **(2,029,831)** | | Cash and cash equivalents at beginning of period | 3,341,738 | 3,865,481 | | **Cash and cash equivalents at end of period** | **2,825,484** | **1,627,832** | [Unaudited Notes to the Interim Condensed Consolidated Financial Statements](index=7&type=section&id=Unaudited%20Notes%20to%20the%20Interim%20Condensed%20Consolidated%20Financial%20Statements) [General Information](index=7&type=section&id=1.%20General%20information) Addex is a Swiss clinical-stage biopharma firm developing allosteric modulators for neurological disorders - The company is a clinical-stage biopharmaceutical firm developing novel small molecule allosteric modulators for neurological disorders[14](index=14&type=chunk) - The company holds a 20% equity interest in Neurosterix US Holdings LLC, which was acquired as part of a major transaction[15](index=15&type=chunk) - The company's shares are traded on the SIX Swiss Exchange (ADXN) and its American Depositary Shares (ADSs) are traded on the Nasdaq Stock Market (ADXN)[16](index=16&type=chunk) [Material Accounting Estimates and Judgments](index=8&type=section&id=3.%20Material%20accounting%20estimates%20and%20judgments) Management highlights a material uncertainty about its going concern status, with cash funding operations only to mid-June 2026 - **Going Concern Warning:** A material uncertainty exists that raises substantial doubt about the Group's ability to continue as a going concern as existing cash is only expected to fund operations through mid-June 2026[22](index=22&type=chunk) - The business faces risks from health pandemics and geopolitical events that could disrupt clinical trials, supply chains, and the ability to raise capital[23](index=23&type=chunk) - The divestment of its drug discovery platform to Neurosterix in Q1 2024 is accounted for as a discontinued operation, for which it received a 20% equity interest[24](index=24&type=chunk)[25](index=25&type=chunk) [Segment Reporting](index=10&type=section&id=5.%20Segment%20reporting) The company operates as a single segment, with Q1 2025 income derived solely from services provided by Neurosterix - The company operates in a single operating segment: the discovery, development, and commercialization of small-molecule pharmaceutical products[33](index=33&type=chunk) Income by Major Counterparty (in Swiss francs) | Counterparty | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Indivior PLC | - | 233,480 | | Neurosterix Group | 71,055 | - | | Other counterparties | - | 1,430 | | **Total** | **71,055** | **234,910** | [Revenue from Contract with Customer](index=19&type=section&id=16.%20Revenue%20from%20contract%20with%20customer) The company recorded no revenue in Q1 2025, and Janssen terminated its license agreement for ADX71149 post-quarter - The research agreement with Indivior PLC generated no revenue in Q1 2025 as it was completed in 2024; in Q1 2024, it had recognized CHF 0.2 million[70](index=70&type=chunk) - **Janssen Agreement Terminated:** On April 17, 2025, Janssen terminated the license agreement for ADX71149 after a Phase 2a epilepsy trial failed its primary endpoint, returning all IP to Addex[72](index=72&type=chunk) - No revenue was recognized from the Janssen agreement in either Q1 2025 or Q1 2024[73](index=73&type=chunk) [Operating Costs](index=22&type=section&id=18.%20Operating%20costs) Total operating costs from continuing operations decreased by 34% to CHF 0.68 million due to lower R&D and professional fees - The decrease in operating costs was mainly driven by a CHF 0.1 million reduction in external R&D and a CHF 0.1 million reduction in professional fees[77](index=77&type=chunk) Operating Costs from Continuing Operations (in Swiss francs) | Cost Category | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | External research and development cost | 32,583 | 179,110 | | Professional fees | 302,382 | 452,010 | | Staff costs | 101,042 | 68,682 | | **Total operating costs** | **677,317** | **1,023,002** | [Discontinued Operations](index=23&type=section&id=21.%20Discontinued%20operations) The company divested its drug discovery platform to Neurosterix for CHF 5.0 million cash and a 20% equity stake - On April 2, 2024, the Group completed the divestment of its allosteric modulator drug discovery technology platform and preclinical programs to Neurosterix Pharma Sàrl[82](index=82&type=chunk) - As consideration for the transaction, Addex received gross proceeds of **CHF 5.0 million in cash and a 20% equity interest** in Neurosterix US Holdings LLC[82](index=82&type=chunk) Financial Performance of Discontinued Operations (in Swiss francs) | Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Operating loss | - | (1,917,978) | | Legal fees related to the sale | - | (428,311) | | **Total net loss from discontinued operations** | **-** | **(2,351,961)** | [Interests in Associates](index=25&type=section&id=22.%20Interests%20in%20associates) The carrying value of the company's 20% equity interest in Neurosterix decreased to CHF 6.24 million - The initial 20% equity interest in Neurosterix was valued at CHF 9.43 million on April 2, 2024; the loss recognized reflects R&D and G&A expenditures incurred by Neurosterix[90](index=90&type=chunk) Change in Carrying Amount of Investment in Neurosterix (in Swiss francs) | Description | Amount | | :--- | :--- | | Beginning of the period (Jan 1, 2025) | 7,087,142 | | Share of net loss of Neurosterix Group | (847,451) | | **End of the period (Mar 31, 2025)** | **6,239,691** | [Events After the Balance Sheet Date](index=27&type=section&id=25.%20Events%20after%20the%20balance%20sheet%20date) Post-quarter, Addex raised CHF 0.67 million from treasury share sales and Janssen terminated its ADX71149 license - From April 1, 2025, to the report's issuance date, the Group sold 11,094,913 treasury shares for **total gross proceeds of CHF 669,102**[97](index=97&type=chunk) - On April 17, 2025, Janssen terminated the license agreement for ADX71149, and the program was returned to the Group[97](index=97&type=chunk)
Addex Therapeutics Reports Q1 2025 Financial Results and Provides Corporate Update
Globenewswire· 2025-06-19 05:00
Core Viewpoint - Addex Therapeutics reported a strong start to 2025 with significant progress in product development and business milestones, particularly in their GABAB PAM drug candidate for chronic cough and regained rights to their Phase 2 mGlu2 PAM asset, ADX71149 [2][5]. Financial Summary - Income for Q1 2025 was CHF 71,000, a decrease of CHF 164,000 from CHF 235,000 in Q1 2024 [4]. - R&D expenses decreased to CHF 156,000 from CHF 245,000, a reduction of CHF 89,000 [4][8]. - G&A expenses decreased to CHF 521,000 from CHF 778,000, a reduction of CHF 257,000 [4][8]. - Total operating loss improved to CHF 606,000 from CHF 788,000, an improvement of CHF 182,000 [4]. - Net loss from continuing operations was CHF 1,473,000, compared to CHF 735,000 in Q1 2024, an increase of CHF 738,000 [4]. - Net loss for the period decreased to CHF 1,473,000 from CHF 3,087,000, a reduction of CHF 1,614,000 [4][9]. - Basic and diluted net loss per share was CHF 0.01, down from CHF 0.03 in the same period last year [4][10]. - Cash and cash equivalents increased to CHF 2.8 million from CHF 1.6 million, an increase of CHF 1.2 million [4][11]. - Shareholders' equity improved significantly to CHF 8.3 million from a negative CHF 1.4 million [4]. Operational Highlights - The GABAB PAM chronic cough candidate demonstrated robust anti-tussive activity in multiple disease models [5][6]. - The company regained rights to its Phase 2 mGlu2 PAM asset, ADX71149 [5][6]. - Indivior successfully advanced their GABAB PAM program for substance use disorders through IND enabling studies [5][6]. - An option agreement was entered with Sinntaxis for exclusive licensing of intellectual property related to mGlu5 NAM in brain injury recovery [5][6].
Addex Therapeutics to Release Q1 2025 Financial Results and Host Conference Call on June 19, 2025
Globenewswire· 2025-06-18 05:00
Group 1 - Addex Therapeutics will release its Q1 2025 Financial Results on June 19, 2025, followed by a business update and product pipeline review during a teleconference and webcast [1][2] - The teleconference will be held at 16:00 CEST (15:00 BST / 10:00 EDT / 07:00 PDT) [2] - Addex Therapeutics focuses on developing novel small molecule allosteric modulators for neurological disorders, with its lead drug candidate, dipraglurant, under evaluation for brain injury recovery [3] Group 2 - Addex's partner, Indivior, has selected a GABAB PAM drug candidate for substance use disorders and completed IND enabling studies [3] - The company is also advancing an independent GABAB PAM program for chronic cough and holds a 20% equity interest in Neurosterix LLC, which is developing allosteric modulator programs for various neurological conditions [3] - Addex shares are listed on the SIX Swiss Exchange and NASDAQ under the ticker symbol "ADXN" [3]
Addex GABAB PAM Candidate Demonstrates Robust Anti-Tussive Activity in Multiple Chronic Cough Preclinical Models
Globenewswire· 2025-06-06 05:00
Core Viewpoint - Addex Therapeutics announced significant anti-tussive activity of its GABAB positive allosteric modulator (PAM) in preclinical models, indicating potential as a treatment for chronic cough [1][3][4] Company Overview - Addex Therapeutics is a clinical-stage biopharmaceutical company focused on developing novel small molecule allosteric modulators for neurological disorders [6] - The company’s lead drug candidate, dipraglurant, is being evaluated for brain injury recovery [6] - Addex has a partnership with Indivior for a GABAB PAM drug candidate aimed at substance use disorders, which has completed IND enabling studies [6] Product Development - The GABAB PAM drug candidate demonstrated significant reductions in cough frequency and increased cough latency in preclinical models, outperforming reference drugs like nalbuphine, baclofen, and codeine [3][4] - The candidate showed better tolerability and a wider therapeutic margin compared to nalbuphine and baclofen, while being comparable to a P2X3 inhibitor [3] - The company is preparing to advance the GABAB PAM candidate into IND enabling studies following positive in vivo proof of concept [4] Scientific Background - GABAB receptors are crucial in the cough neural circuit, and activating these receptors has been clinically validated with baclofen, which has limitations due to side effects and loss of efficacy [5] - The allosteric modulation approach offers advantages such as higher selectivity and better tolerability compared to traditional orthosteric compounds [5]
Addex to Present Positive GABAB PAM Chronic Cough Data at the 10th American Cough Conference
Globenewswire· 2025-06-05 05:00
Core Insights - Addex Therapeutics is a clinical-stage biopharmaceutical company focused on developing novel small molecule allosteric modulators for neurological disorders [4] - The company announced the presentation of preclinical data for its GABAB positive allosteric modulator cough program at the 10th American Cough Conference [1][2] Company Overview - Addex's lead drug candidate is dipraglurant, a negative allosteric modulator targeting mGlu5, currently under evaluation for brain injury recovery [4] - The company is advancing an independent GABAB PAM program specifically for chronic cough, while also collaborating with Indivior on a GABAB PAM drug candidate for substance use disorders [4] - Addex holds a 20% equity interest in Neurosterix LLC, which is developing a portfolio of allosteric modulator programs for various neurological conditions [4] Presentation Details - The presentation will be led by Mikhail Kalinichev, Head of Translational Science, discussing the antitussive efficacy of Compound A in guinea pig models [2][3] - The presentation is scheduled for June 7, 2025, at 11:20 am EST [7] Scientific Background - GABAB receptors are crucial in the cough neural circuit and are activated by the neurotransmitter GABA [3] - Current treatments like baclofen have limitations, and targeting allosteric sites may offer advantages such as higher selectivity and better tolerability [3]
Addex Convenes Annual General Meeting 2025
Globenewswire· 2025-06-03 05:00
Core Points - Addex Therapeutics, a clinical-stage biopharmaceutical company, focuses on developing novel small molecule allosteric modulators for neurological disorders [4] - The company's lead drug candidate, dipraglurant, is being evaluated for brain injury recovery, including post-stroke and traumatic brain injury recovery [4] - The 2025 Annual General Meeting (AGM) is scheduled for June 24, 2025, at 11:00 am CEST in Geneva, Switzerland [1] Agenda Items - Approval of the Annual Report, Annual Financial Statements, and Consolidated Financial Statements for the business year 2024 [2] - Consultative vote on the Compensation Report for the business year 2024 [3] - Re-elections of the Board of Directors, including Vincent Lawton as Chairman [3] - Approval of compensation for the Board of Directors and Executive Management [3] Company Overview - Addex holds a 20% equity interest in Neurosterix LLC, which is advancing allosteric modulator programs for various neurological conditions [4] - The company is also developing a GABAB PAM drug candidate in partnership with Indivior for substance use disorders [4] - Addex shares are listed on the SIX Swiss Exchange and NASDAQ under the ticker symbol "ADXN" [4]
Addex Therapeutics(ADXN) - 2024 Q4 - Annual Report
2025-05-15 20:01
Financial Performance - The company incurred accumulated losses totaling CHF 353 million since inception, but generated a net profit of CHF 7.18 million for the twelve-month period ended December 31, 2024, primarily due to reduced operating losses and proceeds from divesting part of its business to Neurosterix[32]. - As of December 31, 2024, the company had cash and cash equivalents of CHF 3.3 million, which are expected to fund operating expenses through mid-June 2026[35][36]. - The company has raised an aggregate of CHF 355.4 million in equity financing and generated CHF 66.8 million in revenue since its inception through December 31, 2024[159]. Business Operations and Development - The company has no products on the market and may never commercialize its drug candidates, with none currently approved for marketing or in Phase 3 trials[39]. - The company is dependent on its partner Indivior for the development and commercialization of its drug candidates, which exposes it to significant risks[43]. - The company expects to increase expenses in the medium and long term as it continues the development of its GABAB PAM chronic cough drug candidate and seeks marketing approval for its drug candidates[33]. - The company may need significant additional capital to fund its continued development activities and may be unable to raise such capital when needed[31][35]. - The company faces risks related to health pandemics and geopolitical issues that could disrupt its operations and clinical trials[40]. - The company relies on third-party collaborations for drug development, which may impact the commercialization of drug candidates if partnerships fail[46]. - Clinical trials and preclinical studies are dependent on third-party performance, and any delays or failures could adversely affect development timelines[47]. - The company does not have in-house manufacturing capabilities, relying on third-party suppliers, which poses risks of supply interruptions or quality issues[48]. - Regulatory approval for drug candidates is uncertain, and even successful trials may not guarantee approval from agencies like the FDA or EMA[49]. - Clinical testing is expensive and time-consuming, with potential for delays or failures at any stage of the process[50]. - The company may face competition from larger pharmaceutical firms with more resources, which could hinder its ability to successfully develop and market drugs[52]. - The company is focused on developing GABAB PAM for substance use disorder, with a significant commercial opportunity identified[138]. - The company plans to initiate a Phase 2a clinical study for dipraglurant, pending funding or a development partner[140]. - The company aims to develop a best-in-class treatment for chronic cough through precise targeting of the GABAB receptor, addressing a significant unmet medical need[130]. Intellectual Property and Legal Risks - The company holds 9 U.S. patents and 130 foreign patents, but the validity and enforceability of these patents are uncertain[54]. - The company may be restricted by third-party patents, which could limit its ability to develop and commercialize drug candidates[55]. - Protecting intellectual property rights is crucial, and breaches or failures to secure agreements could adversely affect the company's competitive position[56]. - Legal disputes over intellectual property could divert resources and management attention, impacting overall business operations[57]. - The company is subject to extensive government regulations that could increase development costs or delay commercialization[61]. - The company may face potential fines and penalties for non-compliance with anti-corruption laws, which could harm its business operations[74]. - The company is exposed to risks related to data privacy and cybersecurity breaches, which could result in significant penalties and reputational damage[80]. Market and Regulatory Environment - The company may be deemed a "passive foreign investment company" for U.S. federal income tax purposes, which could have adverse consequences for U.S. holders of its shares[37]. - Changes in healthcare laws and regulations may impact the company's ability to sell drug candidates and could lead to decreased reimbursement rates[65]. - The Inflation Reduction Act of 2022 introduces price negotiation for certain drugs, which may affect revenue generation starting in fiscal year 2023[66]. - Future healthcare reforms could impose price controls and affect the competitive landscape for drug pricing[71]. - The potential for reference pricing in European countries may restrict sales potential unless drugs are significantly differentiated from existing options[71]. - The company is subject to significant uncertainty regarding third-party coverage and reimbursement for its drug candidates, which may adversely affect market acceptance and financial results[73]. Compliance and Reporting - The company expects to incur significant legal, accounting, and compliance costs as it operates with securities listed in both the United States and Switzerland[94]. - The company qualifies as a foreign private issuer, which allows it to follow less stringent reporting obligations compared to U.S. domestic public companies[109]. - The company is classified as an "emerging growth company" until December 31, 2025, allowing it to take advantage of reduced reporting requirements[114]. - The company reported that its internal control over financial reporting was not effective as of December 31, 2024, due to two material weaknesses identified[118]. - The company anticipates that the loss of its emerging growth company status may make its ADSs less attractive to investors, potentially affecting trading volume and price[116]. Shareholder Information - The company currently lacks internal sales, marketing, and distribution capabilities necessary for successful commercialization[59]. - The company has never paid dividends on its share capital and does not anticipate paying cash dividends in the foreseeable future[99]. - As of December 31, 2024, there were 69,683,409 shares reserved for issuance under the existing equity incentive plan, including 61,676,618 warrants[100]. - The company may face challenges in maintaining an active market for its ADSs, which have traded on Nasdaq since January 29, 2020[96]. - Holders of ADSs may not have the same voting rights as holders of shares and may not receive voting materials in time[101]. - The rights of holders of shares are governed by Swiss law, which differs from the rights of shareholders in typical U.S. corporations[105]. Development Pipeline - The company has a pipeline of proprietary clinical and preclinical stage drug candidates targeting diseases with no approved therapies, including post-stroke recovery and substance use disorder[127]. - The lead development compound, dipraglurant, is under evaluation for post-stroke and traumatic brain injury recovery, with a collaboration agreement with Sinntaxis AB announced on April 30, 2025[128]. - The second development compound, ADX71149, was terminated by partner Janssen due to lack of statistical significance in Phase 2 study, and the program has been returned to the company for future evaluation[129]. - The company completed a funded research program for GABAB PAM for chronic cough in 2024, with plans to advance its own independent program[130]. - The company divested its allosteric modulator discovery platform to Neurosterix Pharma Sàrl on April 2, 2024, receiving gross proceeds of CHF 5.0 million and a 20% equity interest in Neurosterix US Holdings LLC[134]. - Neurosterix US Holdings LLC secured USD 65.0 million in funding commitments from investors, enhancing the financial backing for its drug development initiatives[134]. - The company has established a portfolio of clinical and preclinical programs, with ongoing efforts to secure grants and subsidies to offset development costs[131]. - The company is developing multiple chemical series of GABAB PAMs and has selected a drug candidate for refractory chronic cough, expecting to initiate IND enabling studies subject to securing funding or a development partner[181].
Addex Partner Indivior Advances GABAB Positive Allosteric Modulator Program Successfully Through IND Enabling Studies
Globenewswire· 2025-05-12 05:00
Core Insights - Addex Therapeutics announced that its partner Indivior has successfully advanced the GABAB positive allosteric modulator (PAM) program through IND enabling studies, marking the final preclinical development stage before clinical studies can commence [1][2] - Addex is eligible for payments up to USD 330 million based on the achievement of regulatory, clinical, and commercial milestones, along with tiered royalties on net sales ranging from high single digits to low double digits [2] Company Overview - Addex Therapeutics is a clinical-stage biopharmaceutical company focused on developing novel small molecule allosteric modulators for neurological disorders [4] - The company's lead drug candidate, dipraglurant, is under evaluation for brain injury recovery, including post-stroke and traumatic brain injury recovery [4] - Addex holds a 20% equity interest in Neurosterix LLC, which is advancing a portfolio of allosteric modulator programs for various neurological conditions [4] GABAB PAM Program - The GABAB PAM program is aimed at treating substance use disorders and has successfully completed preclinical safety and toxicity studies [2][3] - The activation of the GABAB receptor is clinically validated, with existing agonists like baclofen showing efficacy in multiple disease areas, although their use is limited due to side effects [3] - Novel PAMs are expected to provide efficacy with fewer adverse effects and less tolerance compared to direct agonists [3]